Your browser does not support JavaScript! PERFORM (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]
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PERFORM (menthol) spray
[Performance Health LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active Ingredients

Menthol USP   10.4% 

Purpose

Cooling Pain Relief

Uses:

Soothing On-The-Go temporary relief from minor aches and pains associated with sore muscles, strains, joint discomfort, arthritis.

Warnings:

For external use only.

Flammable:

Keep away from excessive heat or open flame.

Ask a Doctor Before Using This Product If You: Have sensitive skin, are pregnant or are breastfeeding.

When Using This Product:

  • Avoid contact with eyes or mucous membranes
  • Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops
  • Do not bandage or use with a heating pad or device, ointments, creams, sprays, liniments

Stop Use and Ask a Doctor If:

Condition worsens, symptoms persist more than 7 days, or clear up and reoccur.

Keep Out of Reach of Children:

If ingested, get medical help. Contact Poison Control Center immediately.

Directions:

  • Adults / Children 12 years and older:  Apply on to affected area up to 4 times daily
  • Children under 12 years of age:  Consult a physician

Other Information:

Store in a cool, dry place out of direct sunlight.

Inactive Ingredients:

Arnica Extract, Eucalyptus Oil, Ilex Paraguariensis Extract, Lavender Oil, Lime Oil, Natural Camphor USP, Nutmeg Oil, Orange Oil, Peppermint Oil, Pine Oil, Polysorbate 20, SD Alcohol 39-C, Thyme Oil, Purified Water, White Tea Extract

Questions or Comments?

1-800-755-2584

Representative Labeling

59316-109-27

PERFORM 
menthol spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59316-109
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL104 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA 
EUCALYPTUS OIL 
ILEX PARAGUARIENSIS LEAF 
LAVENDER OIL 
LIME OIL 
CAMPHOR (SYNTHETIC) 
NUTMEG OIL 
ORANGE OIL 
PEPPERMINT OIL 
WHITE PINE OIL 
POLYSORBATE 20 
THYME OIL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-109-2710 in 1 BOX
11 mL in 1 PATCH
2NDC:59316-109-29118 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/10/2013
Labeler - Performance Health LLC (794324061)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging Services LLC557434805manufacture(59316-109)
Establishment
NameAddressID/FEIBusiness Operations
Tapemark Company006154595manufacture(59316-109)

Revised: 2/2014
 
Performance Health LLC

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